Impact of the Therapeutic Education on the Quality of Life of the Child From 8 to 12 Years Old (and His Family) Suffering of Food Allergy IgE-mediated.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Child FAQLQ global score
研究概览
简要总结
The purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy.
This study also show us if therapeutic education has an effect on the quality of life of child's family.
详细描述
Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the forbidden allergen. The child and his family have to learn to deal with this risk. Therapeutic education can help the children to take care of their allergy.
Food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. In the day of today, there is no cure treatment. Also, improve the quality of life is one of the goals of the food allergy management.
The impact of therapeutic education on quality of life has never been studied. We intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with IgE mediated food allergy.
Our hypothesis is the quality of life can be improved by therapeutic education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE mediated food allergy
- •Child from 8 to 12 years old (included)
- •Family who can have an internet access
- •Children which parents have received study's information
- •Child who can have a medical examination before inclusion (art. L.1121-11 du CSP).
- •Patients who have a medical insurance.
排除标准
- •Non IgE mediated food allergy
- •Child with chronic disease, except asthma and atopic dermatitis
- •Patients who already had a therapeutic education for food allergy
- •Patient already included in another study
研究组 & 干预措施
Therapeutic education group
At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the doctors offer patients randomized to therapeutic education to have a therapeutic education before the 4th month.
The sessions will be led by a multidisciplinary equip. Each child and his family will have a therapeutic session (2 times 2 hours).
干预措施: Therapeutic education group (Behavioral)
Control group
At first, all patients will be invited to participate in a study of troop having for objective to estimate their quality of life. Then, the patients randomized in this group will have the habitual medical care.
结局指标
主要结局
Child FAQLQ global score
时间窗: month 12
次要结局
- Child FAQLQ global score(month 6)
- All cause which can be influence the quality of life, especially occurrence of anaphylactic reactions(month 12)
- Parent FAQLQ global score(month 12)